Department of Oncology, the Second People's Hospital of Yibin City, Yibin, Sichuan, China.
Laboratory Medicine, the Second People's Hospital of Yibin City, Yibin, Sichuan, China.
Cancer. 2023 Jul 1;129(13):1995-2003. doi: 10.1002/cncr.34771. Epub 2023 Apr 12.
This study aims to test the efficacy of single-photon emission computed tomography (SPECT)-defined active bone marrow-sparing (ABMS) volumetric-modulated arc therapy (VMAT) in reducing grade 3+ acute hematologic toxicity (HT) in locally advanced cervical cancer patients treated with chemoradiotherapy.
This was a prospective, single-center, open label, randomized clinical trial that enrolled locally advanced cervical cancer patients. Participants were randomized to the Tc sulfur colloid SPECT-defined ABMS VMAT (ABMS group) or control group, who received weekly cisplatin concurrently with VMAT followed by high-dose-rate intracavitary brachytherapy. The ABMS group additionally received SPECT-defined ABM dose constraints. The primary end point was the incidence of grade 3+ acute HT.
A total of 192 Federation of Gynaecology and Obstetrics stage IB-IIIB patients were randomly treated (96 each in the ABMS control groups). The median follow-up was 24.0 months. The incidence of grade 3+ acute HT in the ABMS group was significantly lower than that in the control group (32.3% vs. 53.1%, p < .01). The number of patients completing five cycles of cisplatin was 88.5% in the ABMS group and 75% in the control group, and the difference was significant (p = .02). There were no differences in planning target value coverage, organs at risk dosimetric parameters, 2-year progression-free survival, or 2-year overall survival between the two groups. Patients in the control group had nonsignificantly worse 2-year distant metastasis than patients in the ABMS group (17.8% vs. 11.1%, p = .19).
ABMS VMAT significantly reduced grade 3+ acute HT and improved chemotherapy delivery compared with the control treatment. We found weak evidence of the effect of ABMS VMAT on distant metastasis.
本研究旨在测试单光子发射计算机断层扫描（SPECT）定义的主动骨髓保护（ABMS）容积调制弧形治疗（VMAT）在降低同期放化疗局部晚期宫颈癌患者 3 级以上急性血液学毒性（HT）方面的疗效。
这是一项前瞻性、单中心、开放标签、随机临床试验，入组了局部晚期宫颈癌患者。参与者被随机分为 Tc 硫胶体 SPECT 定义的 ABMS VMAT（ABMS 组）或对照组，对照组接受每周顺铂联合 VMAT 治疗，然后进行高剂量率腔内近距离治疗。ABMS 组还接受了 SPECT 定义的 ABM 剂量限制。主要终点是 3 级以上急性 HT 的发生率。
共有 192 名妇科肿瘤学联合会（FIGO）分期 IB-IIIB 患者被随机治疗（ABMS 组和对照组各 96 例）。中位随访时间为 24.0 个月。ABMS 组 3 级以上急性 HT 的发生率明显低于对照组（32.3% vs. 53.1%，p<0.01）。ABMS 组完成五周期顺铂化疗的患者比例为 88.5%，对照组为 75%，差异有统计学意义（p=0.02）。两组间计划靶区覆盖、危及器官剂量学参数、2 年无进展生存率和 2 年总生存率无差异。对照组患者 2 年远处转移率明显高于 ABMS 组（17.8% vs. 11.1%，p=0.19）。
ABMS VMAT 与对照组相比，显著降低了 3 级以上急性 HT 的发生率，提高了化疗的完成率。我们发现 ABMS VMAT 对远处转移的影响证据较弱。
